Actively Recruiting
Advancing Diagnosis and Treatment of Pediatric Asthma by Deep Immunophenotyping and Evaluation of Two Spacer Devices for Inhaled Corticosteroid Administration
Led by Luxembourg Institute of Health · Updated on 2026-03-30
208
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
L
Luxembourg Institute of Health
Lead Sponsor
L
Luxembourg National Research Fund
Collaborating Sponsor
AI-Summary
What this Trial Is About
Asthma is a common chronic condition in children that requires proper inhaler use and consistent medication to manage symptoms effectively. This research aims to study if a new digital inhaler can improve how well children aged 5 to 16 with partly controlled or uncontrolled asthma use their inhaled corticosteroids. The study also looks at biological markers and environmental factors that might affect asthma control and treatment response in these children. Participants with asthma will be randomly assigned to use either a standard inhaler called AeroChamber Plus® Flow-Vu® or a new digital inhaler called the Whizz spacer, which monitors inhalation and links to a mobile app. Both groups will use their assigned inhaler for 12 weeks. Additionally, children without asthma will be included for a single visit to provide comparison biological samples. During the study, children will complete daily diaries of their inhaler use and asthma control questionnaires at the start, middle, and end of the 12 weeks. They will undergo lung function tests, give biological samples, and provide dust samples from their bedrooms. Physical activity will be tracked using a bracelet worn for 7 days at the beginning and end of the study. Researchers will measure adherence to treatment, asthma control, inflammatory markers, and environmental exposure throughout the trial.
CONDITIONS
Brief Title
Advancing Diagnosis and Treatment of Pediatric Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged between 5-16 years, male or female
- Physician diagnosis of asthma requiring controller treatment with inhaled corticosteroids or inhaled corticosteroids/long-acting beta-agonists via metered dose inhaler
- Partly controlled or uncontrolled asthma based on GINA criteria
- Informed consent signed by legally authorized representatives and assent from children aged 10 years or older
You will not qualify if you...
- Severe asthma exacerbation treated with systemic corticosteroids within the last 2 weeks or active respiratory tract infection
- Diagnosis of chronic lung disease other than asthma (e.g., COPD, cystic fibrosis)
- Severe asthma based on GINA definitions
- Severe underlying disorders such as severe congenital heart disease or cancer
- Immune deficiency or use of immunosuppressive treatments
- Receiving immunotherapy (for participants donating samples for biomarker research)
- Neurological diseases or impaired cognitive disorders
- Siblings of patients already included in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants with asthma use either the Whizz spacer or the AeroChamber Plus® Flow-Vu® to inhale their corticosteroid medication.
Regular use of inhaler devices during the 12 weeks
Duration - At baseline and at 12 weeks
Participants are assessed for asthma control, inflammatory markers, immunophenotyping, environmental exposure, and physical activity at the end of the 12-week treatment period.
2 visits (baseline and end of intervention)
Trial Site Locations
Total: 1 location
1
Luxembourg Research Clinic (LRC)
Luxembourg, Luxembourg
Actively Recruiting
Research Team
C
Christiane Hilger, PhD
A
Ali Znati
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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